Question
number
Question definition
1 Was true randomization used for assignment of participants to treatment groups?
2 Was allocation to treatment groups concealed?
3 Were treatment groups similar at baseline?
4 Were participants blind to treatment assignment?
5 Were those delivering the treatment blind to treatment assignment?
6 Were treatment groups treated identically other than the intervention of interest?
7 Were outcome assessors blind to treatment assignment?
8 Were outcomes measured in the same way for treatment groups?
9 Were outcomes measured in a reliable way?
10 Was follow-up complete, and if not, were differences between groups in follow-up adequately described and analysed?
11 Were participants analysed in the groups to which they were randomized (intention-to-treat analysis)?
12 Was appropriate statistical analysis used?
13 Was the trial design appropriate, and were deviations from the standard RCT design accounted for?